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EC number: 942-643-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The substance lutetium aluminium oxide, cerium doped, garnet is not irritating to the skin and not irritating to the eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-04-14 to 2009-04-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: ca. 13 weeks
- Weight at study initiation: 3.0 kg, 3.8 kg, 3.1 kg
- Housing: Semi barrier in an air-conditioned room, housed in ABS - plastic rabbit cages, floor 4200 cm2
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2009-04-09 To: 2009-04-18 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: Untreated right side of the body served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): enough for moistening the test item
- Lot/batch no. (if required): B. Braun Melsungen, lot 8221A121
- Purity: ca. 100 % - Duration of treatment / exposure:
- Initial test: 4h
Main test: 4 h - Observation period:
- For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
For the initial test in one animal, the test site was also examined immediately after the patch has been removed. - Number of animals:
- Initial test: 1
Main test: 2 - Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 h - Irritation parameter:
- erythema score
- Basis:
- other: All 3 animals
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- other: All 3 animals
- Time point:
- other: 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- other: All 3 animals
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- other: All 3 animals
- Time point:
- other: 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: All 3 animals
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: All 3 animals
- Time point:
- other: 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: All 3 animals
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: All 3 animals
- Time point:
- other: 72 h
- Score:
- 0
- Irritation parameter:
- other: systemic findings, specific local findings
- Basis:
- other: All 3 animals
- Time point:
- other: 1 h
- Remarks on result:
- other: no systemic findings, no specific local findings
- Irritation parameter:
- other: systemic findings, specific local findings
- Basis:
- other: All 3 animals
- Time point:
- other: 24 h
- Remarks on result:
- other: no systemic findings, no specific local findings
- Irritation parameter:
- other: systemic findings, specific local findings
- Basis:
- other: All 3 animals
- Time point:
- other: 48 h
- Remarks on result:
- other: no systemic findings, no specific local findings
- Irritation parameter:
- other: systemic findings, specific local findings
- Basis:
- other: All 3 animals
- Time point:
- other: 72 h
- Remarks on result:
- other: no systemic findings, no specific local findings
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not irritant, not corrosive.
- Executive summary:
Under the conditions of the present study, single dermal application of the test item L174 to rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the criteria for classification and labelling requirements of the CLP-Regulation (as well as the DSD 2001/59/EC), the test item L174 does not have to be classified and has no obligatory labelling requirement for skin irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-04-20 to 2009-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: 3.2 kg, 2.8 kg, 3.1 kg
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- acclimatisation: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/-10 %
- Air changes (per hr): at least 10/h
- Photoperiod (hrs dark / hrs light):12 h light, 12 h dark
IN-LIFE DATES: From: 2009-04-15 To: 2009-04-25 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No rinsing after application.
- Time after start of exposure: 72 h
SCORING SYSTEM: Grading of ocular lesion
Cornea: Degree of density (opacity, densest are taken for reading. Score 0 - 4
Iris: Score 0 - 2
Conjunctiva: Redness (refers to palpebral and bulbar conjunctiva; excluding cornea and iris. Score 0 - 3
Conjunctiva: Chemosis, swelling (refers to lids and/or nictitating membranes). Score 0 - 4 - Irritation parameter:
- cornea opacity score
- Basis:
- other: all 3 animals
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: all 3 animals
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- other: all 3 animals
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: all 3 animals
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all 3 animals
- Time point:
- other: 24 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: all 3 animals
- Time point:
- other: 24 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- other: all 3 animals
- Time point:
- other: 24 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: all 3 animals
- Time point:
- other: 24 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all 3 animals
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: all 3 animals
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- other: all 3 animals
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: all 3 animals
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all 3 animals
- Time point:
- other: 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: all 3 animals
- Time point:
- other: 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- other: all 3 animals
- Time point:
- other: 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: all 3 animals
- Time point:
- other: 72 h
- Score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritating to the eye.
- Executive summary:
The eye irritating potential of L174 was examined in a GLP guideline study according to OECD 405.
Under the conditions of the present study, single ocular application of the test item L174 to rabbits at a dose of 0.1 g produced no irritant effects. Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria of DSD (Directive 2001/59/EC) and the CLP-Regulation (EC) 1272/2008, the test item L174 does not have to be classified for eye irritation.
Reference
Control negative in all animals 1 h, 24 h , 48 h and 72 h after application.
No individual systemic and local findings (clinical signs of toxicity) were found in any of the 3 animals 1 h, 24 h, 48 h and 72 h after application of the test item.
The body weights of 2 animals remained constant throughout the observation period. The 3rd animal gained 0.1 kg body weight during the observation period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The variation L174 was tested for the potential to cause skin irritation in a GLP guideline study according to OECD 404.
The substance did not exhibit skin irritation or skin corrosion.
The same irritative/corrosive profile is expected for other variations of the substance lutetium aluminium oxide, cerium doped, garnet.
The variation L174 was tested for the potential to cause eye irritation in a GLP guideline study according to OECD 405.
The substance did not exhibit eye irritation or eye corrosion.
The same irritative/corrosive profile is expected for other variations of the substance lutetium aluminium oxide, cerium doped, garnet.
Justification for selection of skin irritation / corrosion endpoint:
Available GLP guideline study
Justification for selection of eye irritation endpoint:
Available GLP guideline study
Justification for classification or non-classification
Lutetium aluminium oxide, cerium doped, garnet did not show any potential to cause dermal irritation or dermal corrosion.
Lutetium aluminium oxide, cerium doped, garnet did not show any potential to cause eye irritation or eye corrosion.
C&L is not required.
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